The following data is part of a premarket notification filed by Osmetech Molecular Diagnostics with the FDA for Esenor Fii-fv-mthfr Genotyping Test, Esenor Fii-fv Genotyping Test, Esenor Fii Genotyping.
| Device ID | K093974 |
| 510k Number | K093974 |
| Device Name: | ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING |
| Classification | Test, Factor V Leiden Mutations, Genomic Dna Pcr |
| Applicant | OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE. Pasadena, CA 91105 |
| Contact | Robert S Dicheck |
| Correspondent | Robert S Dicheck OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE. Pasadena, CA 91105 |
| Product Code | NPQ |
| Subsequent Product Code | NPR |
| Subsequent Product Code | NSU |
| Subsequent Product Code | OMM |
| CFR Regulation Number | 864.7280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-04-22 |